510(k) · Cleared
ClearedStomach Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Co., Ltd. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 11, 2017 as substantially equivalent to K022112 (Fortune Medical Instrument Corp., 2003) and 1 other predicate after a 415-day review. Its family tree reaches back 7 generations to 1981.
- Decided
- Oct 11, 2017
- Review
- 415 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K810156 (1981). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK810156 Argyle Salem Sump TubeSherwood Medical Co. · 1981 · Recalled
- 6 generations backK971354 Knott NG TubeMichael M. Knott, M.D. · 1997
- 5 generations backK020005 Infant Feeding TubesPromedic, Inc. · 2002
- 4 generations backK052903 Pediatric Feeding TubePromedic, Inc. · 2005
- 3 generations backK072756 Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
- 2 generations backK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
- 1 generation backK092628 Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010
- This deviceK162340 Stomach TubeWell Lead Medical Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K810156 | Argyle Salem Sump Tube | Sherwood Medical Co. | 1981 | 3 |
| −6 | K971354 | Knott NG Tube | Michael M. Knott, M.D. | 1997 | — |
| −5 | K020005 | Infant Feeding Tubes | Promedic, Inc. | 2002 | — |
| −4 | K052903 | Pediatric Feeding Tube | Promedic, Inc. | 2005 | — |
| −3 | K072756 | Non-IV Adapter for Infant NG Tube | Promedic, Inc. | 2007 | — |
| −2 | K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set | Neochild, LLC | 2009 | — |
| −1 | K092628 | Enteral Feeding Tube and Accessories, Feeding Tube Extension Set | Alan Reid | 2010 | — |
| 0 (this device) | K162340 | Stomach Tube | Well Lead Medical Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022112 | Fortune All Silicone Stomach (Gastric) Tubes, Model 2020Summary page 4…ion Name: Gastrointestinal tube and accessories Product Code: KNT Regulatory Class: Class II Predicate Device(s): K022112-All Silicone Stomach (Gastric) Tube 1. Intended Use The Stomach Tube is intended for gastric decompression. It is used to drain… | 2003 |
| * | K092628 | Enteral Feeding Tube and Accessories, Feeding Tube Extension SetSummary page 5…used in the same populations. Thus, the Stomach Tube is substantially equivalent to the All Silicone Stomach (Gastric) Tube(K022112) and Pediatric Enteral Feeding Tube(K092628). 4. Summary of Non-Clinical Performance Testing The following performance testing was conducted for the Stomach Tube: 1) Gener… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 13 ancestors have a recall of any class.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162340 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162340: Stomach Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162340
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026